The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.
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Phase Ib: Incidence and Severity of Adverse Events (AEs)
Timeframe: Up to 36 months
Phase Ib: Number of Participants With Dose-Limiting Toxicity (DLTs)
Timeframe: From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
Phase II: Progression-free Survival (PFS)
Timeframe: Up to 36 months
Reference Study ID Number: GO46021 https://forpatients.roche.com/